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Intraocular Lens

TECNIS® Intraocular Lens for Cataracts

N/A
Recruiting
Research Sponsored by Johnson & Johnson Surgical Vision, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be at least 22 years old
Patient must have cataracts in both eyes
Must not have
Patient has uncontrolled pressure in the eye
Patient has poorly controlled diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial will be conducted at multiple locations on both sides of the body and will involve an intervention. It will be carefully controlled and will involve random assignment of participants. The trial will be masked, meaning

Who is the study for?
This trial is for English-speaking adults at least 22 years old with cataracts in both eyes who can sign consent and attend follow-up visits. It's not suitable for those unable to comply with the study procedures or complete questionnaires.Check my eligibility
What is being tested?
The study compares two types of intraocular lenses (IOLs) used in cataract surgery: a control lens (Model DCB00) and a test lens (Model DEN00V). Participants will be randomly assigned to receive one of these lenses, in a masked setup where the sponsor, subjects, and evaluators do not know which lens is given.See study design
What are the potential side effects?
Potential side effects may include discomfort, redness or swelling around the eye, blurred vision, glare, halos around lights, or other visual disturbances following implantation of either IOL model.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 22 years old.
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I have cataracts in both eyes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have uncontrolled eye pressure.
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My diabetes is not well-managed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Monocular Depth of Focus
Monocular Photopic BCDVA at 4m
Monocular Photopic DCVA at 100 cm
+1 more
Secondary outcome measures
Monocular photopic DCNVA at 40 cm (first eyes)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Test IOLExperimental Treatment1 Intervention
DEN00V
Group II: Control IOLActive Control1 Intervention
DCB00

Find a Location

Who is running the clinical trial?

Johnson & Johnson Surgical Vision, Inc.Lead Sponsor
35 Previous Clinical Trials
8,056 Total Patients Enrolled
30 Trials studying Cataract
6,827 Patients Enrolled for Cataract
Johnson & Johnson Surgical Vision, Inc. Clinical TrialStudy DirectorJohnson & Johnson Surgical Vision, Inc.
8 Previous Clinical Trials
4,041 Total Patients Enrolled
7 Trials studying Cataract
4,006 Patients Enrolled for Cataract
~167 spots leftby Oct 2025